MARK3 (UDI 9091)

Manufactured by CARGUS INTERNATIONAL, INC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The MARK3 (Model/Catalog Number: 9091) is a medical device manufactured by CARGUS INTERNATIONAL, INC. This product is indexed under FDA Product Code / Category Classification KLE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 9091
Product Code / EMDN: KLE
Device Name: Etchant Gel 37% Bulk Pack 25/bx. (25x1.2ml. Syr. & 50 Tips) - MARK3
Database Sync Date: 2026-08-09 09:05:50

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of MARK3?

The registered manufacturer of record for MARK3 is CARGUS INTERNATIONAL, INC.

What is the Primary UDI-DI identifier for MARK3?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9091.

What classification code is assigned to this device?

This device is registered under product classification code KLE.

Similar Classification Devices (KLE)

Other Devices by CARGUS INTERNATIONAL, INC

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